Coupling Agent Produced From Naturally Fermented And Sustainable Additives

ABSTRACT

A coupling agent composition is provided and includes a plurality of non-toxic components in an amount equal to or greater than 97 weight percent (wt %). The coupling agent composition includes a carrier of water, at least one water soluble polyol selected from the group consisting of propanediol, pentylene glycol, and butylene glycol, a thickening agent having a naturally derived soluble polymer additive selected from a group consisting of xanthan gum, carrageenan, guar, locust bean, sodium hyaluronate, sodium alginate, acacia, tara gum, tamarind seed, succinoglycan, scleroglucan, and mannan, and a balance of incidental impurities.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/297,762, filed Oct. 19, 2016, and issued as U.S. Pat. No. 10,646,597and U.S. patent application Ser. No. 16/484,502, filed Apr. 14, 2020,claiming priority under 35 U.S.C. § 119.

FIELD OF THE INVENTION

The invention relates to a coupling agent and, more particularly, acoupling agent containing naturally fermented and sustainable additives.

BACKGROUND

An ultrasound coupling agent, otherwise known as a “gel”, is designed toact as a conductive barrier between an ultrasound probe and the outerlayer of skin, known as the epidermis. A gel providing excellentacoustics is a necessity in order to produce the appropriate reflectionof sound waves useful to a valid diagnosis.

In order to properly transmit ultrasonic impulses, the gel must be amedium that can uniformly produce uninterrupted quantitative parametersfor measurement of acoustic velocity, impedance, and attenuation. Theseparameters are all necessary to yield a competent diagnosis viaultrasound technology.

Ultrasound diagnostic procedures are used in assessing and diagnosing awide variety of medical conditions related to internal organs. Perhapsthe condition most familiar to the general public is with regard todevelopment of a fetus during pregnancy. Ultrasonography uses ultrasoundscanning to produce images on a cathode ray tube or television screen.It is widely used in obstetrics for several purposes, includingconfirming pregnancy under circumstances where hormonal tests cannot beused, for establishing gestational age and the number of fetuses, fordetermining sex of the fetus, for detecting fetal abnormalities or fetaldeath, for monitoring fetal growth, as an adjunct to amniocentesis, etc.Ultrasound Doppler scanning may also be used to test fetal blood flow.Ultrasonography is a valuable technique, since it provides a safealternative to roentographic or X-ray techniques.

The procedure typically will involve the application of a gel to thepatient's abdomen. A piezoelectric transducer that generates sound wavesat a frequency in the range of 2.25 to 7.0 MHz is placed in the gel andmoved across the abdomen to form images at different angles. The soundwaves reflect off tissues to produce an echo signal that can beconverted to images that can be viewed on a screen and interpreted by acompetent medical practitioner. The gel lubricates the abdomen andprevents the sound waves from being trapped or reflected by air pocketsthat might distort the image and lead to an incorrect diagnosis.Typically, after completion of the ultrasound examination, any remaininggel is wiped off the patient's abdomen. For instance, U.S. Pat. No.8,133,516 discloses lubricants used for medicinal purposes and to skincare compositions, and particularly to a therapeutic ultrasound gel usedas a lubricant during ultrasonography procedures that enhances thetransmission of sound waves and that also helps to prevent the formationof stretch marks.

While several gels are available, there is still a need for a gel thatcan enhance the transmission of sound waves from the transducer into theabdominal cavity while at the same time containing ingredients that aremedically safe and non-toxic.

Coupling agents have never fit into the “environmentally friendly andsustainable” category because of the chemical formulation(s) typicallyused in manufacturing. The known commercially available coupling agentshave high concentrations of known irritants like propylene glycol orsuspected estrogen mimics such as parabens. These molecules aresynthetically derived from other than renewable materials.

Increasingly, manufacturers of personal care products are responding tocustomer interest in more environmentally friendly and sustainablysourced products. Regulatory schemes including those of federal andstate governments increasingly reflect these concerns, as well.

Propylene glycol is a known general purpose coupling agent that is oftenused in ambient temperature in thickness gauging applications on smoothsurfaces. Glycerin is also another known general purpose coupling agent,but it is more viscous and has higher acoustic impedance than propyleneglycol. This property makes it a preferred coupling agent for roughsurfaces and highly attenuating materials. However, these and otherknown ultrasound coupling agents typically have high concentrations ofknown irritants and/or estrogen mimics. In fact, many of these knowncoupling agents include one or more toxic components known to be toxicunder California Proposition 65 (1986) (seehttp://oehha.ca.gov/proposition-65/proposition-65-list).

The United States Department of Agriculture (USDA) set forth organicregulations in the Federal Code of Regulations (CFR) in Title 7,subtitle 205. Accordingly, a nontoxic component is a component not knownto cause any adverse physiological effects in animals, plants, humans,or the environment. Under § 205.200—General—the producer or handler of aproduction or handling operation intending to sell, label, or representagricultural products as “100 percent organic,” “organic,” or “made withorganic (specified ingredients or food group(s))” must comply with theapplicable provisions of this subpart. As a result, production practicesimplemented in accordance with that section must maintain or improve thenatural resources of the operation, including soil and water quality.

Thus, it is desirable to obtain a coupling agent having one or morenon-toxic components that are environmentally friendly and sustainableand derived from a natural resource that utilizes the resource, itconstituent parts, and its by-products in a variety of uses and in amanner that reduces waste.

SUMMARY

A coupling agent composition is provided and includes a plurality ofnon-toxic components in an amount equal to or greater than 97 weightpercent (wt %). The coupling agent composition includes a carrier ofwater, at least one water soluble polyol selected from the groupconsisting of propanediol, pentylene glycol, and butylene glycol, athickening agent having a naturally derived soluble polymer additiveselected from a group consisting of xanthan gum, carrageenan, guar,locust bean, sodium hyaluronate, sodium alginate, acacia, tara gum,tamarind seed, succinoglycan, scleroglucan, and mannan, and a balance ofincidental impurities.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a comparative chart displaying measured acoustic velocitiesfor various known coupling agents and a proposed coupling agentaccording to the invention.

DETAILED DESCRIPTION OF THE EMBODIMENT(S)

The following text sets forth a broad description of various exemplaryembodiments of the invention. The description is to be construed asexemplary only and does not describe every possible embodiment sincedescribing every possible embodiment would be impractical, if notimpossible. It will be understood that any feature, characteristic,component, composition, ingredient, product, step or methodologydescribed herein can be deleted, combined with or substituted for, inwhole or part, any other feature, characteristic, component,composition, ingredient, product, step or methodology described herein.Numerous alternative embodiments could be implemented, using eithercurrent technology or technology developed after the filing date of thispatent, which would still fall within the scope of the claims. Allpublications and patents cited herein are incorporated herein byreference.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. In case of conflict, thepresent application including the definitions will control. Also, unlessotherwise required by context, singular terms shall include pluralitiesand plural terms shall include the singular. All publications, patents,and other references mentioned herein are incorporated by reference intheir entireties for all purposes.

Unless otherwise specified, when the following abbreviations are usedherein, they have the following meaning:

As used herein, the terms “comprises,” “comprising,” “includes,”“including,” “has,” “having,” “contains,” or “containing,” or any othervariation thereof, will be understood to imply the inclusion of a statedinteger or group of integers but not the exclusion of any other integeror group of integers. For example, a composition, a mixture, a process,a method, an article, or an apparatus that comprises a list of elementsis not necessarily limited to only those elements but can include otherelements not expressly listed or inherent to such composition, mixture,process, method, article, or apparatus. Further, unless expressly statedto the contrary, “or” refers to an inclusive or and not to an exclusiveor. For example, a condition A or B is satisfied by any one of thefollowing: A is true (or present) and B is false (or not present), A isfalse (or not present) and B is true (or present), and both A and B aretrue (or present).

Also, the indefinite articles “a” and “an” preceding an element orcomponent of the invention are intended to be nonrestrictive regardingthe number of instances, that is, occurrences of the element orcomponent. Therefore “a” or “an” should be read to include one or atleast one, and the singular word form of the element or component alsoincludes the plural unless the number is obviously meant to be singular.

The term “invention” or “present invention” as used herein is anon-limiting term and is not intended to refer to any single embodimentof the particular invention but encompasses all possible embodiments asdescribed in the application.

As used herein, the term “about” modifying the quantity of an ingredientor reactant of the invention employed refers to variation in thenumerical quantity that can occur, for example, through typicalmeasuring and liquid handling procedures used for making concentrates orsolutions in the real world; through inadvertent error in theseprocedures; through differences in the manufacture, source, or purity ofthe ingredients employed to make the compositions or to carry out themethods; and the like. The term “about” also encompasses amounts thatdiffer due to different equilibrium conditions for a compositionresulting from a particular initial mixture. Whether or not modified bythe term “about,” the claims include equivalents to the quantities. Inone embodiment, the term “about” means within 10% of the reportednumerical value, alternatively within 5% of the reported numericalvalue.

“Biomass” as used herein refers to a natural product containinghydrolyzable polysaccharides that provide fermentable sugars includingany sugars and starch derived from natural resources such as corn, sugarcane, wheat, cellulosic or lignocellulosic material and materialscomprising cellulose, hemicellulose, lignin, starch, oligosaccharides,disaccharides and/or monosaccharides, and mixtures thereof. Biomass mayalso comprise additional components such as protein and/or lipids.Biomass may be derived from a single source or biomass can comprise amixture derived from more than one source. For example, biomass maycomprise a mixture of corn cobs and corn stover, or a mixture of grassand leaves. Biomass includes, but is not limited to, bioenergy crops,agricultural residues, municipal solid waste, industrial solid waste,sludge from paper manufacture, yard waste, waste sugars, wood andforestry waste. Examples of biomass include, but are not limited to,corn grain, corn cobs, crop residues such as corn husks, corn stover,grasses, wheat, rye, wheat straw, barley, barley straw, hay, rice straw,switchgrass, waste paper, sugar cane bagasse, sorghum, sugar cane, soy,components obtained from milling of grains, trees, branches, roots,leaves, wood chips, sawdust, shrubs and bushes, vegetables, fruits,flowers, animal manure, and mixtures thereof. For example, mash, juice,molasses, or hydrolysate may be formed from biomass by any processingknown in the art for processing the biomass for purposes of fermentationsuch as by milling, treating, and/or liquefying and comprisesfermentable sugar and may comprise water. For example, cellulosic and/orlignocellulosic biomass may be processed to obtain a hydrolysatecontaining fermentable sugars by any method known to one skilled in theart.

An aqueous feed stream may be derived or formed from biomass by anyprocessing known in the art for processing the biomass for purposes offermentation such as by milling, treating, and/or liquefying andcomprises fermentable carbon substrate (e.g., sugar) and may comprisewater.

“Feedstock” as used herein means a feed in a fermentation process, thefeed containing a fermentable carbon source with or without undissolvedsolids, and where applicable, the feed containing the fermentable carbonsource before or after the fermentable carbon source has been liberatedfrom starch or obtained from the breakdown of complex sugars by furtherprocessing such as by liquefaction, saccharification, or other process.Feedstock includes or is derived from a biomass. Suitable feedstocksinclude, but are not limited to, rye, wheat, corn, corn mash, sugarcane,cane mash, barley, cellulosic material, lignocellulosic material, ormixtures thereof. Where reference is made to “feedstock oil,” it will beappreciated that the term encompasses the oil produced from a givenfeedstock.

“Fermentation medium” as used herein means the mixture of water, sugars,dissolved solids, optionally microorganisms producing alcohol, productalcohol, and all other constituents of the material held in thefermentation vessel in which product alcohol is being made by thereaction of sugars to alcohol, water, and carbon dioxide (CO.sub.2) bythe microorganisms present. At the end of a fermentation run the sugarsmay be depleted from the fermentation medium. From time to time, as usedherein the term “fermentation broth” and “fermented mixture” can be usedsynonymously with “fermentation medium.”

“Fermentable carbon source” or “fermentable carbon substrate” as usedherein means a carbon source capable of being metabolized by themicroorganisms disclosed herein for the production of fermentativealcohol. Suitable fermentable carbon sources include, but are notlimited to, monosaccharides such as glucose or fructose; disaccharidessuch as lactose or sucrose; oligosaccharides; polysaccharides such asstarch or cellulose; C5 sugars such as xylose and arabinose; one carbonsubstrates including methane; and mixtures thereof.

“Fermentable sugar” as used herein refers to one or more sugars capableof being metabolized by the microorganisms disclosed herein for theproduction of fermentative alcohol.

“Sugar” as used herein refers to oligosaccharides, disaccharides,monosaccharides, and/or mixtures thereof. The term “saccharide” alsoincludes carbohydrates including starches, dextrans, glycogens,cellulose, pentosans, as well as sugars.

As used herein, “recombinant microorganism” refers to microorganismssuch as bacteria or yeast, that are modified by use of recombinant DNAtechniques, for example, by engineering a host cell to comprise abiosynthetic pathway such as a biosynthetic pathway to produce an apolyol such as propanediol.

“Renewable resource” refers to a natural resource that can bereplenished within a 100 year time frame. The resource may bereplenished naturally, or via agricultural techniques. Renewableresources include plants, animals, fish, bacteria, fungi, and forestryproducts. They, may be naturally occurring, hybrids, or geneticallyengineered organisms. Natural resources such as crude oil, coal, andpeat which take longer than 100 years to form are not considered to berenewable resources.

“Organic natural resource materials” are resources that can bereplenished, either through biological reproduction or other naturallyreoccurring processes in a finite amount of time. Organic naturalresources are known to be environmentally friendly and sustainable.

Throughout the specification a “natural” material is one which has beenharvested, mined or collected, and which subsequently may have beenprocessed, without chemical reaction, to yield a chemical or chemicalsthat are identifiable in the original source material. The phrase“without chemical reaction” permits washing, decolorizing, distilling,grinding, milling, separating and/or concentrating the material byphysical means. By “naturally derived”, we mean materials wherein themajority of the molecule (by weight) is derived from natural materials.

According to the present invention, it has been found that the aboveobjects and advantages can be accomplished through an ultrasoundcoupling agent having a composition with one or more non-toxiccomponents greater than 97 weight percent (wt %).

In an embodiment of the invention, the coupling agent compositionincludes a plurality of non-toxic components derived from one or moreorganic natural resource material and in an amount equal to or greaterthan 97 wt %, a thickening agent in an amount of 0.05-5 wt %, and abalance of incidental impurities.

In an exemplary embodiment of the invention, the one or more non-toxiccomponents includes a carrier and an organic natural resource material.

In a proposed coupling agent composition, the carrier is water,preferably deionized water or distilled water. In particular, the partsof water are 75.00-98.00 wt % in the proposed coupling agentcomposition. In another exemplary embodiment of the invention, theproposed coupling agent composition includes a carrier having a wt %range of 85.00-90.00%. In another exemplary embodiment of the invention,the proposed coupling agent composition includes a carrier having a wt %range of 87.00-89.00%.

One skilled in the art should appreciate that the carrier can be variousknown water types, including water that has been neutralized with analkali hydroxide such as sodium hydroxide or potassium hydroxide to a pHvalue in the range of 6.0 to 8.0.

According to the invention, the organic natural resource material isextracted and/or produced from one or more organic natural resourcesusing known fermentation and/or enzymatic synthesis. For instance, thefermentation and/or enzymatic synthesis may be a known natural chemicalprocess in which bacteria or yeast converts organic materials, such assugars or biomass waste streams, into various types of high value-addedchemicals.

According to the invention, the organic natural resource material is atleast one water soluble polyol. In particular, the parts of solublepolyol are 1.00-25.00 wt % in the proposed coupling agent composition.In another exemplary embodiment of the invention, the proposed couplingagent composition includes a soluble polyol having a wt % range of5.00-15.00%. In another exemplary embodiment of the invention, theproposed coupling agent composition includes a soluble polyol having awt % range of 9.00-11.00%.

The at least one water soluble polyol is selected from the groupconsisting of propanediol, pentylene glycol, and butylene glycol.

Naturally fermented glycols such as propanediol, butylene glycol, andpentylene glycol are useful in the proposed coupling agent composition.Pentylene glycol is a humectant used in cosmetics and beauty productsthat is also secondarily used as a solvent and preservative potentiator.It is both water- and oil-soluble and can have moisture-binding andantimicrobial properties that are well known to one skilled in the art.

In an exemplary embodiment, the at least one water soluble polyol ispropanediol, and more specifically is 1, 3-propanediol. The propanediolis a colorless and highly pure glycol derived from a known sustainableand renewable corn sugar fermentation process. This is a 100 percentbio-based ingredient that boosts preservative efficacy and eliminatesskin irritation caused by glycols used in known coupling agents. Forinstance, known 1, 3-propanediol, such as the brand Zemea® (DuPont Tate& Lyle Bio Products), can be used to replace non-biologically derivedglycols used in known coupling agents, such as propylene glycol (1,2-propanediol), butylene glycol (1,3-/1/4-butanediol), and glycerin.

In another exemplary embodiment, the pentylene glycol is 1,5-pentanediol and may be used as the at least one water soluble polyol.The 1, 5-pentanediol is used as an alternative to known glycols and maybe derived through known processes such as hydrogenation of glutaricacid and its derivatives or hydrogenation of furfural followed byhydrogenolysis of the substituted tetrahydrofuran. For instance, knownpentylene glycol, such as the brand Diol PD™ (Kokyu Alcohol Kogyo Co.Ltd.) can be used to replace synthetically derived glycols used in knowncoupling agents, such as propylene glycol (1,2-propanediol) or glycerin.

In another exemplary embodiment, the at least one water soluble polyolis butylene glycol, and more specifically is 1, 3-butanediol. Thebutylene glycol is used as an alternative to known glycols and may bederived from biomass-derived glucose using known processes. In one knownprocess, genetically- and metabolically-engineered Escherichia coli arecultured in fed-batch fermentation. The 1,3-butylene glycol metabolicpathway consists of four enzymatic steps from acetyl-CoA and uses phaAencoding acetyl-CoA acetyltranferase from Ralstonia eutropha; phaBencoding NADPH-dependent acetacetyl-CoA reductase from R. eutropha; bldencoding butyryl-CoA dehydrogenase from Clostridiumsaccharoperbutylacetonicum; and adh encoding alcohol dehydrogenaseinherent in the host strain E. coli BW/ac/q. (Enhancement Of(R)-1,3-Butanediol Production By Engineered Escherichia Coli Using ABioreactor System With Strict Regulation Of Overall Oxygen TransferCoefficient and Ph; Naoya Kataoka et al. Bioscience, Biotechnology andBiochemistry, Vol. 78, Issue 4, Apr. 23, 2014;http://dx.doi.org/10.1080/09168451.2014.891933). For instance, known 1,3-butylene glycol, such as the brand Haisugarcane BG (CAS RN 107-88-0)(Kokyu Alcohol Kogyo Co. Ltd.) can be used to replace glycols used inknown coupling agents, such as propylene glycol (1,2-propanediol) orglycerin.

According to the invention, a fermentation and/or enzymatic synthesisuses bacteria or yeast to convert organic materials, such as sugars orbiomass waste, into the water soluble polyol. The water soluble polyolis then combined with the carrier to provide a proposed coupling agentcomposition.

In the proposed coupling agent composition, the thickening agent is arheology modifier with parts of the composition of 0.00-5.00 wt %. Inanother exemplary embodiment of the invention, the proposed couplingagent composition includes a thickening agent having a wt % range of0.10-1.00%. In another exemplary embodiment of the invention, theproposed coupling agent composition includes a thickening agent having awt % range of 0.05-0.70%.

In an exemplary embodiment, the thickening agent is a non-toxic solubleor swellable polymer. In particular, the thickening agent may be across-linked polymer selected from a group consisting of hydrophobicpolyacrylate or hydrophilic polyacrylate. The thickening agent may benatural or synthetic. If the thickening agent is synthetic, then thethickening agent portion of the proposed coolant gel composition is lessthan or equal to 3.00 wt %, according to an exemplary embodiment of theinvention.

According to the invention, the thickening agent may include acrosslinked polyacrylate, which may be selected from a group consistingof carbomer, sodium acryloyldimethyltaurate/VP Crosspolymer,acrylates/C10-30 alkyl acrylate crosspolymer, or crosslinked PVP. Inanother exemplary embodiment of the invention, the proposed couplingagent composition includes a crosslinked polyacrylate having a wt %range of 0.10-2.00%.

In an exemplary embodiment, the crosslinked polyacrylate is carbomer,which is used to achieve desired rheological properties in the proposedcoupling agent composition. For instance, known carbomer, such as thebrand Carbopol® Ultrez 30 Polymer (The Lubrizol Corporation, Wickliffe,Ohio) can be used.

In an exemplary embodiment, the crosslinked polyacrylate is a sodiumacryloyldimethyltaurate/VP crosspolymer. The sodiumacryloyldimethyltaurate/VP crosspolymer may be used to achieve desiredrheological properties in the proposed coupling agent composition.

For instance, known sodium acryloyldimethyltaurate/VP crosspolymer, suchas the brand Aristoflex® (AVS) (Clariant Corporation, Charlotte, N.C.)can be used.

In another exemplary embodiment, the crosslinked polyacrylate is anacrylate/C10-30 alkyl acrylate crosspolymer, which may be used toachieve desired rheological properties in the proposed coupling agentcomposition. For instance, a known acrylate/C10-30 alkyl acrylatecrosspolymer, such as the brand Carbopol® Ultrez 21 (The LubrizolCorporation, Wickliffe, Ohio), can be used.

In another exemplary embodiment, the crosslinked polyacrylate iscrosslinked polyvinylpyrrolidone (PVP). The crosslinked PVP is used toachieve desired rheological properties in the proposed coupling agentcomposition. For instance, a known crosslinked PVP, such as the brandFlexiThix™ (Ashland Inc., Covington, Ky.), can be used.

According to the invention, the thickening agent may include one or morenaturally derived additives. In another exemplary embodiment of theinvention, the proposed coupling agent composition includes one or morenaturally derived additives having a wt % range of 0.50-3.00%. In anexemplary embodiment of the invention, the one or more naturally derivedadditives is a soluble polymer and may be selected from a groupconsisting of xanthan gum, guar, locust bean, sodium hyaluronate,glucomannan, carrageenan, sodium alginate, acacia, tara gum, tamarindseed, mannan, succinoglycan, microcrystalline cellulose, andscleroglucan.

In an exemplary embodiment of the invention, the proposed coupling agentcomposition includes a thickening agent additive having a wt % range of0.10-3.00%. In another exemplary embodiment of the invention, theproposed coupling agent composition includes a thickening agent additivehaving a wt % range of 0.2-2.00%. In another exemplary embodiment of theinvention, the proposed coupling agent composition includes a thickeningagent additive having a wt % range of 0.10-0.30%. In yet anotherexemplary embodiment of the invention, the proposed coupling agentcomposition includes a thickening agent additive having a wt % range of1.60-1.80%.

According to the invention, the proposed coupling agent composition mayinclude a biocide agent. The biocide agent may be in a range of 0.25 to1 weight percent of the proposed coupling agent composition. The biocideagent may be selected from a group consisting of phenoxyethanol, benzylalcohol, caprylyl glycol, ethylhexylglycerin, decylene glycol, glycerylcaprylate, and 1,2-hexanediol.

In an exemplary embodiment of the invention, the proposed coupling agentcomposition includes a biocide agent having a wt % range of 0.10-1.00%.In another exemplary embodiment of the invention, the proposed couplingagent composition includes a biocide agent having a wt % range of0.25-0.60%. In another exemplary embodiment of the invention, theproposed coupling agent composition includes a biocide agent having a wt% of 0.50%.

According to the invention, the proposed coupling agent composition mayalso include a neutralizing agent. The neutralizing agent may be in arange of 0.05 to 0.50 weight percent of the proposed coupling agentcomposition. The neutralizing agent may be selected from a groupconsisting of sodium hydroxide, triethanolamine, tromethamine, arginine,and lysine.

In an exemplary embodiment of the invention, the proposed coupling agentcomposition includes a neutralizing agent having a wt % range of0.00-1.00%. In another exemplary embodiment of the invention, theproposed coupling agent composition includes a neutralizing agent havinga wt % range of 0.10-0.30%. In another exemplary embodiment of theinvention, the proposed coupling agent composition includes aneutralizing agent having a wt % range of 0.20-0.25%.

According to the invention, the proposed coupling agent composition mayalso include a chelating agent. The chelating agent may be in a range of0.025 to 0.10 weight percent of the proposed coupling agent composition.The neutralizing agent may be selected from a group consisting ofdisodium EDTA and sodium phytate.

In an exemplary embodiment of the invention, the proposed coupling agentcomposition includes a chelating agent having a wt % range of0.01-1.00%. In another exemplary embodiment of the invention, theproposed coupling agent composition includes a chelating agent having awt % range of 0.03-0.07%. In another exemplary embodiment of theinvention, the proposed coupling agent composition includes aneutralizing agent having a wt % of 0.05%.

According to the invention, the proposed coupling agent composition mayinclude filler materials or have a balance of incidental impurities.

The present invention can be illustrated by the following examples ofproposed coupling agent compositions according to the invention withoutbeing limited by them. Each of the following examples was prepared beingdependent on an organic natural resource material in view of overallpercentage of non-toxic component.

Table 1 shows an exemplary embodiment of a proposed coupling agentcomposition according to the invention.

TABLE 1 Compositional Element Weight Percent (wt %) Carrier  75.00-98.00% Organic natural resource    1.00-25.00% materialThickening agent    0.10-1.00% Biocide agent    0.10-1.00% Neutralizingagent    0.10-0.30% Thickening agent additive    0.10-1.00% Chelatingagent 0.05% Percent Natural ~97.00-100%

Table 2 shows another exemplary embodiment of a proposed coupling agentcomposition according to the invention.

TABLE 2 Compositional Element Weight Percent (wt %) Carrier  75.00-98.00% Organic natural resource    1.00-25.00% materialThickening agent additive    0.10-0.30% Biocide agent    0.10-1.00%Chelating agent    0.01-0.05% Percent Natural ~97.00-100%

Table 3 shows an exemplary embodiment of a proposed coupling agentcomposition according to the invention.

TABLE 3 Compositional Element Weight Percent (wt %) Weight Percent (wt%) Deionized water   75.00-98.00% 88.43% Propanediol    1.00-25.00%10.00% Acrylate/C10-30 alkyl    0.10-1.00%  0.60% acrylate crosspolymerBenzyl alcohol    0.10-1.00%  0.50% Sodium Hydroxide    0.10-0.30% 0.22% Xanthan gum    0.10-1.00%  0.20% Disodium EDTA 0.05%  0.05%Percent Natural ~97.00-100% 98.63%

Table 4 shows another exemplary embodiment of a proposed coupling agentcomposition according to the invention.

TABLE 4 Compositional Element Weight Percent (wt %) Weight Percent (wt%) Deionized water   75.00-98.00% 88.43% Propanediol    1.00-25.00%10.00% Acrylate/C10-30 alkyl    0.10-1.00%  0.60% acrylate crosspolymerBenzyl alcohol    0.10-1.00%  0.50% Sodium Hydroxide    0.10-0.30% 0.22% Xanthan gum    0.10-1.00%  0.20% Disodium EDTA 0.05%  0.05%Percent Natural ~97.00-100% 98.63%

Table 5 shows another exemplary embodiment of a proposed coupling agentcomposition according to the invention.

TABLE 5 Compositional Element Weight Percent (wt %) Weight Percent (wt%) Deionized water   75.00-98.00% 88.43% 1,5-pentanediol    1.00-25.00%10.00% Acrylate/C10-30 alkyl    0.10-1.00%  0.60% acrylate crosspolymerBenzyl alcohol    0.10-1.00%  0.50% Sodium Hydroxide    0.10-0.30% 0.22% Xanthan gum    0.10-1.00%  0.20% Disodium EDTA 0.05%  0.05%Percent Natural ~97.00-100% 98.63%

Table 6 shows another exemplary embodiment of a proposed coupling agentcomposition according to the invention.

TABLE 6 Compositional Element Weight Percent (wt %) Weight Percent (wt%) Deionized water   75.00-98.00% 88.43% 1,3-butanediol    1.00-25.00%10.00% Acrylate/C10-30 alkyl    0.10-1.00%  0.60% acrylate crosspolymerBenzyl alcohol    0.10-1.00%  0.50% Sodium Hydroxide    0.10-0.30% 0.22% Disodium EDTA    0.10-1.00%  0.05% Xanthan gum 0.05%  0.02%Percent Natural ~97.00-100% 98.63%

Table 7 shows another exemplary embodiment of a proposed coupling agentcomposition according to the invention.

TABLE 7 Compositional Element Weight Percent (wt %) Weight Percent (wt%) Deionized water   75.00-98.00%  87.75% Pentylene Glycol   1.00-25.00%  10.00% Carrageenan    1.0-2.0%  1.70% Benzyl alcohol   0.10-1.00%  0.50% (natural sourced) Xanthan Gum    0.10-0.40%  0.30%Percent Natural ~97.00-100% 100.00%

Table 8 shows an exemplary embodiment of a proposed coupling agentcomposition according to the invention.

TABLE 8 Compositional Element Weight Percent (wt %) Weight Percent (wt%) Deionized water 75.00-98.00%    87.55% Carrageenan  1.00-3.00%   1.70% Sodium Phytate  0.05-0.20%    0.05% 1, 3-Propanediol 1.00-20.00%    10.00% Benzyl alcohol  0.10-1.50%    0.50% (naturalsourced) Xanthan Gum  0.05-1.00%    0.20% Percent Natural ~100% ~100.00%

Table 9 shows an exemplary embodiment of a proposed coupling agentcomposition according to the invention.

TABLE 9 Compositional Element Weight Percent (wt %) Weight Percent (wt%) Deionized water 75.00-98.00% 88.00 Carrageenan  1.00-3.00%    1.70%Sodium Phytate  0.05-0.20%    0.05% Butylene Glycol  1.00-20.00%   10.00% Benzyl alcohol  0.10-1.50%    0.50% (natural sourced) XanthanGum  0.05-1.00%    0.20% Percent Natural ~100% ~100.00%

Table 10 shows an exemplary embodiment of a proposed coupling agentcomposition according to the invention.

TABLE 10 Compositional Element Weight Percent (wt %) Weight Percent (wt%) Deionized water 75.00-98.00%    87.55% Mannan  1.00-3.00%     1.70%Sodium Phytate  0.05-0.20%     0.05% 1, 3-Propanediol  1.00-20.00%   10.00% Benzyl alcohol  0.10-1.50%     0.50% (natural sourced) Xanthangum  0.05-1.00%     0.20% Percent Natural ~100% ~100.00%

In an exemplary description of manufacturing, a coupling agentcomposition according to the invention is processed according to thefollowing steps. However, one skilled in the art should appreciate thatthe following steps are merely exemplary and are used to enable oneskilled in the art to process proposed coupling agent compositionsaccording to the invention.

In an exemplary embodiment of the invention, a thickening agent, such asa cross-linked polyacrylate, is measured out. A first batch ofthickening agent additive, such as a soluble polymer, is measured outand combined with the thickening agent. Next, a first batch of acarrier, such as deionized water, is measured out. The thickening agentand the thickening agent additive are dispersed into the carrier toprepare a first mixture. Next, a first batch of organic natural resourcematerial, such as a polyol, is measured out and combined with achelating agent and a biocide agent. A mixture of the chelating agent,the first batch of organic natural resource material, and the biocideagent is then added to the first mixture of the carrier and thethickening agent.

Next, a slurry is prepared from a second batch of an organic naturalresource material and a second batch of a thickening agent additive.This slurry is added to the mixture of the chelating agent, the firstbatch of organic natural resource material, the biocide agent, the firstmixture of the carrier, and the thickening agent in order to form asource mixture.

Next, a second batch of a carrier is measured out and combined with aneutralizing agent to form a neutralizing mixture. Finally, thisneutralizing mixture is combined with the source mixture.

In an embodiment of the invention, the coupling agent is in a clear gelform.

In an embodiment of the invention, the coupling agent has a viscositygreater than or equal to 10,000 centipoise (cP). According to anembodiment of the invention, the coupling agent has a viscosity between25,000-100,000 cP. According to another embodiment of the invention, thecoupling agent has a viscosity between 75,000-90,000 cP. In yet anotherembodiment of the invention, the coupling agent has a viscosity between83,200 cP. In yet another embodiment of the invention, the couplingagent has a viscosity between 81,667 cP.

The proposed coupling agent composition according to the invention hasexcellent acoustics characteristics. Performance specifications (ranges)of the proposed coupling agent composition that would make it useful inmedical procedures, including ultrasonic diagnostic procedures, include(1) acoustic velocity, (2) impedance, (3) attenuation, and (4)resolution.

In particular, the proposed coupling agent composition has acousticalvelocities very close to that of blood at various temperatures. Thelimited amount of entrapped air in the tested coupling agents minimizedsignal attenuation.

Table 11 lists measured acoustic velocities for various known couplingagents and the proposed coupling agent according to the invention testedat 23C, 32C and 40C. Additionally, Table 11 displays the calculatedwater velocity taken using the Bilaniuk and Wong equation as a markerfor test methodology.

TABLE 11 Acoustic Velocity (m/s) Proposed PRIOR PRIOR PRIOR CalcCoupling Water ART 1 ART 2 ART 3 water

Temp C. 23 1495 1561 1564 1582 1491 1558 32 1509 1572 1572 1589 1513 Notmeasured 40 1521 1579 1578 1589 1528 1561

indicates data missing or illegible when filed

FIG. 1 illustrates a comparative chart displaying measured acousticvelocities for various known coupling agents and the proposed couplingagent according to the invention when tested at 23C, 32C and 40C.Additionally, FIG. 1 displays the calculated water velocity taken usingthe Bilaniuk and Wong equation as a marker for test methodology. Asshown, the measured acoustic velocity of the proposed coupling agent isminimally affected by an increase in temperature, as compare to theprior art coupling agents.

In conclusion, the proposed coupling agent provides more consistentacoustic velocity verses prior art couplants. In fact, the testdemonstrates more drastic changes in acoustic velocity with increasedtemperature. When used in imaging, this deviation in acoustic velocitycould alter the interpretation of a sonogram, for instance.

The foregoing illustrates some of the possibilities for practicing theinvention. Many other embodiments are possible within the scope andspirit of the invention. For instance, the described coupling agentcomposition could be used for various applications including, but notlimited to, ultrasound gels, lubricants, topical gels, and topicaltreatments. It is, therefore, intended that the foregoing description beregarded as illustrative rather than limiting, and that the scope of theinvention is given by the appended claims together with their full rangeof equivalents.

What is claimed is:
 1. A coupling agent composition containing: aplurality of non-toxic components in an amount equal to or greater than97 weight percent (wt %) and having: a carrier of water; at least onewater soluble polyol selected from the group consisting of propanediol,pentylene glycol, and butylene glycol a thickening agent having anaturally derived soluble polymer additive selected from a groupconsisting of xanthan gum, carrageenan, guar, locust bean, sodiumhyaluronate, sodium alginate, acacia, tara gum, tamarind seed,succinoglycan, scleroglucan, and mannan; and a balance of incidentalimpurities.
 2. The composition according to claim 1, wherein thenaturally derived soluble polymer additive is in an amount of 0.50-3.00wt %.
 3. The composition according to claim 2, wherein the at least onewater soluble polyol is in an amount of from 9.00 to 11.00 wt %.
 4. Thecomposition according to claim 3, further comprising a neutralizingagent selected from a group consisting of sodium hydroxide,triethanolamine, tromethamine, arginine, and lysine.
 5. The compositionaccording to claim 4, further comprising a chelating agent selected froma group consisting of disodium EDTA and sodium phytate.
 6. Thecomposition according to claim 5, wherein the neutralizing agent is inan amount of from 0.05 to 0.50 wt %.
 7. The composition according toclaim 6, wherein the chelating agent is in an amount of from 0.025 to0.10 wt %.
 8. The composition according to claim 1, wherein the waterhas a pH in the range of 6.0 to 8.0 wt %.
 9. The composition accordingto claim 1, wherein the at least one water soluble polyol is in anamount of from 9.00 to 11.00 wt %.
 10. The composition according toclaim 9, wherein the wherein the at least one water soluble polyol isprocessed from fermentation or enzymatic synthesis.
 11. The compositionaccording to claim 10, wherein the fermentation or enzymatic synthesisis a natural chemical process using bacteria or yeast to convert organicmaterials.
 12. The composition according to claim 11, wherein thethickening agent is less than or equal to 3 wt %.
 13. The compositionaccording to claim 12, wherein the thickening agent is syntheticnon-toxic swellable polymer.
 14. The composition according to claim 13,wherein the thickening agent is at least one cross-linked polymerselected from a group consisting of hydrophobic polyacrylate orhydrophilic polyacrylate.
 15. The composition according to claim 14,wherein the at least one cross-linked polymer is selected from a groupconsisting of hydrophobic polyacrylate or hydrophilic polyacrylate, 16.The composition according to claim 1, wherein a viscosity of thecomposition is 25000-100000 centipoise.
 17. The composition according toclaim 1, further comprising a biocide agent.
 18. The compositionaccording to claim 17, wherein the biocide agent is selected from agroup consisting of phenoxyethanol, benzyl alcohol, caprylyl glycol,ethylhexylglycerin, decylene glycol, and 1,2-hexanediol.
 19. Thecomposition according to claim 1, wherein the carrier of water and theat least one water soluble polyol is present in an amount of from 15 to19 wt %.
 20. The composition according to claim 19, wherein the at leastone water soluble polyol is propanediol.
 21. The composition accordingto claim 1, wherein the plurality of non-toxic components is propyleneglycol free.